Intranasal Dexmedetomidine VS Oral Chloral Hydrate for Rescue Sedation During Magnetic Resonance Imaging

Guangzhou Women and Children's Medical Center

Status and phase: Completed; Phase 4

Conditions: Chloral Hydrate Adverse Reaction; Administration Related Reaction; Failed Moderate Sedation During Procedure

Treatments: Drug: chloral hydrate Group; Drug: high dose dexmedetomidine group; Drug: low dose dexmedetomidine group

Study type: Interventional

Funder types: Other

Identifiers

NCT02239445

WZhang

Details and patient eligibility

About

The purpose of this investigation was to test the hypothesis that intranasal dexmedetomidine is as effective as second dose of oral chloral hydrate for rescue sedation in infant age between 1 and 6 months who were not adequately sedated following initial dose of chloral hydrate.

Enrollment: 158 patients

Sex: All

Ages: 1 to 6 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 160 children of ASA physical status I or II, aged between 1 and 6 months, failed chloral hydrate sedation during MRI scanning

Exclusion criteria

• known allergy or hypersensitive reaction to dexmedetomidine or CH, organ dysfunction, pneumonia, acute upper respiratory airway inflammation, preterm, cardiac arrhythmia or and congenital heart disease.

Trial design

158 participants in 3 patient groups

chloral hydrate group

Active Comparator group

Description:

chloral hydrate 0.25 mg/kg oral solution diluted with oral syrup to 5 ml and 0.2 mL intranasal placebo (normal saline)

Treatment:

Drug: chloral hydrate Group

low dose dexmedetomidine Group

Experimental group

Description:

Group L received intranasal dexmedetomidine at 1mcg/kg and 5 ml oral syrup Undiluted preservative-free dexmedetomidine (AiBeiNing; Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) was prepared in a concentration of 100mcg/ml and dripped into both nostrils using a 1 mL syringe with the child in the Supine position.

Treatment:

Drug: low dose dexmedetomidine group

high dose dexmedetomidine group

Experimental group

Description:

Group H received intranasal dexmedetomidine at 2mcg/kg and 5 ml oral syrup Undiluted preservative-free dexmedetomidine (AiBeiNing; Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) was prepared in a concentration of 100mcg/ml and dripped into both nostrils using a 1 mL syringe with the child in the Supine position.

Treatment:

Drug: high dose dexmedetomidine group